FDA Regulations on Drug Marketing

Pfizer under fire for lacking safety protocols

On April 9, the FDA announced that Pfizer has failed to correct testing procedures in regards to clinical trials. The FDA says that over two dozen overdoses have occurred in patients participating in trials for the drug Geodon. The warning from the FDA comes on the heels of the federal court criticizing Pfizer’s in-house safety protocols and procedures.

The FDA issued a warning letter to Pfizer saying Pfizer is not properly monitoring physicians testing an experimental medication and as a result, more than two dozen patients have overdosed during the four-year trial. Pfizer first identified problems with the drug and dosing recommendations in 2006, but the FDA says they have failed to fix these procedures. The FDA has given Pfizer fourteen days to submit a new set of policies and procedures for overseeing care of patients within their clinical trials.

Over the last month, Pfizer has come under fire for lacking safety protocols. A former lab employee won a lawsuit against the company blaming ineffectual safety procedures for her contracting an immunovirus and now with clinical trials. Problems with safety are becoming a pattern for Pfizer, one they need to change before a major crisis, like death resulting from a trial drug, hits. Employees, stockholders, and consumers want to know that Pfizer is doing everything it can to keep them safe.

The FDA is providing Pfizer with their first opportunity to turn the pattern around and recommit themselves to safety. By re-evaluating their current safety procedures, Pfizer has the opportunity to figure out what can be improved upon. After evaluating safety protocols within clinical trials, Pfizer’s next safety area needs to be lab procedures. As the field of biopharmaceuticals grows and develops, the risks associated with lab work will grow. There is a need for advanced protocols throughout the entire industry and Pfizer can take this opportunity to put themselves ahead of their competitors.

Pfizer needs to re-evaluate all of its safety procedures and protocols in order to prevent a bigger crisis and avoid future legal troubles.

How engaging in social media now can help crisis communications in the future

Prior to the 1990’s there was very little academic research into crisis management, but as more and more organizations have experienced devastating crises the importance of the field has become more apparent. Today, crisis management is a rapidly changing field with a number of emerging trends for the way in which an organization reacts, both internally and externally.

The development and frequent use of social media tools (i.e. Facebook, Twitter, and blogs) has played a large role in the way stakeholders and publics are being delivered news. Social media allows anyone the freedom to be a gatekeeper and as a result, information on crises is being delivered much quicker and to a much larger audience than before. In addition to information being available quicker and to a larger audience, there is also less fact checking. With less fact checking it becomes difficult for PR pros to control the flow of information and ensure that all publics are being given the most accurate updates on a crisis.

The best way to monitor what publics and social media gatekeepers are saying is to set up accounts on various social media platforms. An organization should have a Twitter account, a Facebook account, a company blog, and Google Alerts set up for anything being said about the company. Pfizer has a Twitter account (@Pfizer_News), a Facebook fan page, and an official company blog. Having these accounts is a great foundation to have lain in the event of a crisis, but the primary purpose of these accounts is disseminating news rather than interacting with its various publics and stakeholders.

Should a crisis hit, Pfizer’s social media accounts will only be useful if they have already built relationships with Twitter, Facebook, and blog users. Communicating with social media gatekeepers is the same as communicating with traditional media. Relationships must be built before an organization can ask a stakeholder or public to do something for them. Pfizer needs to take the time to interact with their followers on Twitter and Facebook and fellow bloggers so they can use these gatekeepers to their best advantage should a crisis hit.

Pfizer Safety Policies

Last month I blogged about a lawsuit brought against Pfizer by a former employee who claimed that Pfizer’s lack safety protocols led to her contracting a virus connected to immunodeficiency diseases. On Thursday, Federal courts in Connecticut awarded Becky McClain $1.37 million stating that Pfizer violated whistle-blower laws by firing Ms. McClain. The courts also highlighted the potential dangers facing scientists who work in biotechnology labs and the need for stricter protocols and procedures.

After a crisis hits, and this is crisis for Pfizer, the most important step an organization can take is to learn from the situation. Regardless of how the organization weathered the crisis, it can only be deemed successful if it then takes the opportunity to re-evaluate its business policies and procedures to ensure a similar crisis does not happen again. Often, the ethical environment of an organization sets the stage for a possible crisis.

The board of directors, motives of top executives, or organizational safety policies, can set ethical environments. In the case of Pfizer, they will need to intently look over their current safety policies and how strictly they are being enforced. With the way the biotechnology industry is evolving, they need to spend the short-term finances now to prevent a future crisis from happening.

Podcast - What healthcare reform means for the pharmaceutical industry

Learning from a Crisis

A few weeks ago, I wrote a post about Pfizer being under investigation by the DOJ for its marketing of an immunosuppressant drug, Rapamune. Until the results of the probe are revealed, it is hard to say what effect it will have on Pfizer; however, in the meantime their communications department and Crisis Management Team should be evaluating what can be learned from this potential crisis.

Many experts believe that crises are both negative situations and opportunities for organizational learning. The success of crisis communications is defined by whether or not an organization learns from each crisis. Levels of learning differ, but the most advance level is to change organizational policies and procedures to prevent a crisis from happening in the future.

In the case of Pfizer’s DOJ probe, the learning should be easy. The Crisis Management Team should begin by evaluating what advertising and marketing is being done on Rapamune and all other drugs. This process could include monitoring any complaints that have been turned in by consumers. Should any violations or problems present itself, Pfizer needs to change its marketing policies and techniques to ensure the problem does not happen again.

Any crisis can be turned into an opportunity if an organization takes the time to evaluate and learn from the crisis. This includes taking steps to change organizational policies and procedures to ensure future crises do not repeat themselves.

Ex-Pfizer Worker Cites Genetically Engineered Virus in Lawsuit over Firing

On Monday of this week, court proceedings began in the suit of a former Pfizer employee who claimed she was fired as the result of being infected by a genetically engineered virus she was working on. Becky McClain alleges that a lack in laboratory safety led her to be infected with a virus that is now causing her intermittent paralysis. McClain also alleges that after she reported her concerns to Pfizer and the US Occupational Safety and Health Administration (OSHA) she was fired for “blowing the whistle” on Pfizer’s below standard safety procedures. McClain has filed her claim under Connecticut’s whistle-blower laws.

McClain’s lawsuit is, in fact, a crisis for Pfizer. A former employee is not only saying that the company failed to protect her personal safety, but they fired her because she tried to tell the world about it. Attacks on companies do not get much worse than this. However, Pfizer is handling this lawsuit and its ensuing crisis beautifully.

Pfizer lucked out in that OSHA is on the drug giant’s side. McClain’s complaint was dismissed after OSHA reviewed the evidence and even went as far as to criticize her for not accepting the accommodations Pfizer was willing to offer (Pfizer offered to move her to a different facility where she would be exposed to less vigorous viruses). With OSHA on their side, Pfizer has a credible third party to state that the company’s safety practices are up to par. A fact that they have been stating to every news outlet that asks for an interview. Pfizer should also consider publishing fact sheets or creating a video of what safety measures are taken in their labs.

Pfizer also claims that McClain was fired for failure to attend work and that the connection made between her symptoms and the virus were made after the fact. If Pfizer can prove that McClain never mentioned a possible connection prior to being fired, she loses her case, as it cannot be filed under the whistle-blower statutes. The company is also doing a great job at utilizing a single spokesperson – public relations specialist, Elizabeth Power. Power is the only person commenting on the case, an important element to ensure continuity in the information being disseminated.

Despite the potential fallout from this lawsuit, Pfizer is doing a great job at sticking to the facts and providing cohesiveness to the messages being disseminated. As long as they keep doing what they are doing, Pfizer should be able to make it out of this crisis without a huge hit to their reputation.